An Operation to Ease Back Pain Bolsters the Bottom Line, Too

A complex operation called spinal fusion has emerged as the treatment of choice for many kinds of unrelenting back pain. A quarter million of the procedures, in which metal rods are screwed into the spine to stabilize it, were performed this year in the United States, three times as many as a decade ago.

But a number of researchers say there is little scientific evidence to show that for most patients, spinal fusion works any better than a simpler operation, the laminectomy. And laminectomies get patients out of the hospital and back to their daily routine much faster. Some people, experts add, would be better off with no surgery at all. Even doctors who favor fusions say that more research is needed on their benefits.

In the absence of better data, critics in the field point to a different reason for the fusion operation's fast rise: money.

Medicare can pay a surgeon as much as four times more for a spinal fusion, some doctors say, as for a laminectomy, an operation in which some bone is removed from the spine to relieve pressure on the spinal cord and nerves. Hospitals also collect two to four times as much, a gulf that has grown steadily as fusion operations have grown more complex. Medicare spent an estimated $750 million last year on spinal fusions, said Sam Mendenhall, the editor and publisher of Orthopedic Network News, a newsletter.

So like hysterectomies or certain forms of prostate surgery, some doctors say, back surgery is an example of how money can influence decisions about which treatments to use -- especially when there is limited evidence about which treatments work best. Indeed, as the nation's biggest health plan, Medicare plays a huge role in shaping American health care, from the kinds of hospitals that get built to the amount of chemotherapy drugs that cancer doctors prescribe.

''The reality of it is, we all cave in to market and economic forces,'' said Dr. Edward C. Benzel, a spine surgeon who is chairman of the Cleveland Clinic Spine Institute. Though doctors, as a rule, should favor the least complicated treatment -- with surgery being the last resort -- Dr. Benzel estimated that fewer than half of the spinal fusions done today were probably appropriate. He described the current system of paying doctors as ''totally perverted.''

Doctors and hospitals are not the only players with a financial stake in fusion operations. Critics blame the companies that make the hardware for promoting more complex fusions without evidence that they are significantly more effective. Some sort of hardware is used in almost 90 percent of lower-back fusions, Mr. Mendenhall said, compared with fewer than half in 1996. Between Medicare and private insurers, the national bill for the hardware alone has soared to $2.5 billion a year, he said.

''A lot of technological innovation serves shareholders more than patients,'' he said.

The hardware makers acknowledge giving surgeons millions of dollars in consulting fees, royalty payments and research grants, but say the money promotes technical and medical advances that improve back care.

''We can't innovate to help patients without these physician relationships,'' said Bob Hanvik, a spokesman for Medtronic, the Minneapolis company that is the biggest maker of spinal hardware. ''Most physicians don't want to give away their time.''

Some former Medtronic employees, however, have accused the company of paying surgeons kickbacks. A lawsuit brought by Scott A. Wiese, a former sales representative, accused Medtronic of trying to persuade surgeons to use its products with offers of first-class plane tickets to Hawaii and nights at the finest hotels. Some of those lucrative consulting contracts, the suit claimed, involved little or no work.

Medtronic said it did nothing wrong, and it denied the accusations in the lawsuit, which was filed in 2001 and settled in 2002. But the company disclosed earlier this year that the federal government was investigating charges that it paid illegal kickbacks to surgeons. Federal officials declined to comment on the investigation, and Medtronic said it would vigorously defend itself.

Still, between the allure of money and the quest for breakthroughs in treatment, some prominent spinal surgeons say that back care has gone astray.

''I see too many patients who are recommended a fusion that absolutely do not need it,'' said Dr. Zoher Ghogawala, a Yale University clinical assistant professor of neurosurgery who is conducting a study comparing spinal fusion with laminectomy. Health experts note that if Medicare is overpaying doctors for back operations, other kinds of care are shortchanged, because the program is budgeted a fixed amount each year for doctor's fees.

Fees vary widely around the country, but several surgeons said that Medicare reimbursed doctors roughly $4,000 for a spinal fusion, versus $1,000 for a laminectomy. Mr. Mendenhall said that hospitals typically collected $16,000 for a fusion -- and $10,000 more for an increasingly common ''360 degree'' operation in which hardware is attached to both the front and back of the spine -- versus $7,000 for a laminectomy.

''The money is driving a lot of this,'' Mr. Mendenhall said. The cost to patients will differ based on their insurance coverage, and patients with traditional Medicare coverage will have to shoulder some of the higher surgeon fees. But some patients may push for what they believe is the most-advanced treatment.

Many spine surgeons defend fusion operations, saying that some patients clearly benefit from them, even if some of the procedures are not warranted.

''There is some indication that if you do it right, it can benefit people,'' said Dr. Eric J. Woodard, a spine surgeon at Brigham & Women's Hospital in Boston, who noted that a well-designed Swedish study recently showed positive results for some patients. More research needs to be done, he added, to identify the category of patients who have the best odds of being helped. In the meantime, Dr. Woodard said, many doctors are being more selective about who gets a fusion operation.

In part, the rise of spinal fusions represents the natural process of medicine. Surgeons perform operations, and when -- as in the case of back pain -- the outcomes are mixed, surgeons strive to improve their techniques.

The Medicare payment system, in turn, rewards complexity, because it lets doctors bill for the individual procedures they perform within a single operation. It also tries to encourage the development of new medical technologies. And the makers of medical devices like fusion hardware exert themselves with frequent success in persuading Medicare to pay for their new products.

Earlier this year, for example, Medtronic persuaded the government to cover a new kind of bone graft material, called Infuse, for use in spinal fusions. Surgeons describe the new material as having the potential to represent a real advance. Still, Medtronic scored a significant coup, experts said, in Medicare's decision to make an additional payment, as much as $4,450, to hospitals to help cover the cost of Infuse, on top of the flat fee paid for the operation.

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''The power of the device industry is growing tremendously,'' including its ability to influence Medicare officials, said Susan Bartlett Foote, a professor of health policy at the University of Minnesota.

Medicare officials are unaware of any problems concerning reimbursements for spinal fusions, an agency spokeswoman said. Industry executives said that Medicare patients deserved quick access to breakthrough treatments that might improve the quality of their lives.

Because of the scant data on the benefits of back operations, patients with similar complaints receive widely differing treatments for their pain, according to a 1999 study by researchers at the Center for the Evaluative Clinical Sciences at Dartmouth College. The National Institutes of Health is doing a large study to determine which patients will benefit from various treatments.

''There is a real paucity of convincing science about spinal fusion in particular,'' said Dr. Richard A. Deyo, a professor of medicine and of health sciences at the University of Washington. He was involved in the attempt by the federal government in the mid-1990's to issue guidelines for back surgery.

The guidelines, which recommended a conservative approach and discouraged surgery, were roundly attacked by spine surgeons. Indeed, the surgeons nearly succeeded in persuading Congress to eliminate financing for the federal Agency for Health Care Policy and Research, which developed the guidelines. Sofamor Danek, the Medtronic unit that makes fusion hardware and was then an independent company, unsuccessfully sued to prevent the agency from making its recommendations public.

Some surgeons are disturbed by the level of influence that industry has on their profession, particularly in research. ''This is a topic which orthopedic surgeons, neurosurgeons and the societies associated with both their groups are definitely concerned about,'' said Dr. Brett A. Taylor, an orthopedic surgeon at Washington University in St. Louis.

The absence of solid research means that patients sometimes have little to go on in deciding whether to have surgery.

Three years ago, Dr. Sam Ho, the chief medical officer of PacifiCare, a California insurer, suddenly developed severe back pain, the result of an extruded disc. His neurosurgeon, he said, insisted that he needed a laminectomy, but the surgeon could not offer any studies indicating that the operation would help. Nor, Dr. Ho said, could the surgeon tell him how many operations he had performed or how his own patients had fared.

Dr. Ho said he refused the surgery and made a complete recovery within two months.

Spinal fusion has a history of controversy. Device makers were the subject of numerous lawsuits in the early 1990's charging that they were paying surgeons illegal kickbacks to use their screws. Most suits were unsuccessful, often because courts were not convinced that the screws had caused injury or pain.

But similar accusations have surfaced in recent years. In his lawsuit, filed in a state court in Los Angeles, Mr. Wiese, the former Medtronic sales representative, said that he was told by his bosses to do ''whatever it takes'' to sell fusion hardware. Two doctors demanded consulting contracts in return for using Medtronic's products, the suit contended, but the contracts were a ''sham,'' because little work was done for the pay. The suit was settled for undisclosed terms, and Mr. Wiese's lawyer declined to comment on the matter.

In interviews, two other former Medtronic employees said that the company engaged in similar practices as recently as last year. They said that Medtronic's sales representatives routinely offered enticements to surgeons to use the company's hardware, including lavish trips and visits to a strip club near the Memphis headquarters of the Sofamor Danek division. The former employees said they had spent as much as $1,000 a night per doctor for a night on the town.

''It's a business deal,'' said one of the employees, who declined to be named because he still works in the medical device industry. ''It takes money to make money.''

A document provided by one of the former employees listed about 80 surgeons who have consulting agreements with Medtronic that pay as much as $400,000 a year.

Mr. Hanvik, the Medtronic spokesman, said that the company had policies in place to prevent its sales agents from providing improper inducements to surgeons. The company works closely with some surgeons, he said, and pays them fairly for their time creating new devices and improving the design of existing products. The annual amounts on the list are the maximum each doctor can receive. ''They only get paid for the work they do,'' he said.

Trying to rise above the flood of money, researchers like Dr. Ghogawala at Yale say they are now conducting studies free of industry support in search of basic answers about the efficacy of back operations. Having raised private money to finance his pilot study comparing fusions and laminectomies, Dr. Ghogawala plans to apply for government financing for a larger, five-year study.

''I think we are identifying who needs it and who does not,'' he said. ''It's critical to know if it's a lot of unnecessary surgery for a lot of people.''

Re-examining Medicare

Since its inception in 1965, Medicare has improved the health of the elderly while playing an outsize role in shaping the delivery of health care for all Americans.

This article is the seventh in a series examining efforts to overhaul Medicare and ways that the rules of the program influence the economics and practice of medicine.

Correction: January 6, 2004, Tuesday Because of an editing error, a front-page article on Wednesday about an increase in the number of spinal-fusion operations misstated the given name of the editor and publisher of Orthopedic Network News, who said Medicare spent $750 million last year on spinal fusions. He is Stan Mendenhall, not Sam.